Pasritamig for Prostate Cancer

(KLK2-comPAS Trial)

Recruiting at 34 trial locations

Overseen By Study Contact

Age: 18+

Sex: Male

Trial Phase: Phase 3

Sponsor: Janssen Research & Development, LLC

Must be taking: GnRH analogs

Must not be taking: Immunosuppressive medications

Disqualifiers: Autoimmune disease, Pulmonary compromise, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 4 years and 8 months

663 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called pasritamig to determine if it extends the lives of people with advanced prostate cancer. The cancer in this study has spread beyond the prostate and no longer responds to hormone treatments. Researchers will compare the effects of pasritamig plus supportive care against a placebo with the same care. Men with prostate cancer that has spread to the bones or lymph nodes and who have tried other treatments might be suitable for this trial. As a Phase 3 trial, this study represents the final step before potential FDA approval, offering participants a chance to contribute to a promising new treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, you must continue any ongoing hormone therapy throughout the treatment phase.

Is there any evidence suggesting that pasritamig is likely to be safe for humans?

Research has shown that pasritamig is generally safe for patients. In earlier studies, pasritamig demonstrated a good safety record, with most participants experiencing no major issues. The studies reported low rates of cytokine release syndrome, a reaction caused by an overactive immune system, which is a positive finding. Most patients did not experience serious side effects, and the treatment was safely administered outside of a hospital setting.

In other trials, pasritamig was used in individuals with advanced prostate cancer who had already tried many other treatments. Even in these cases, pasritamig proved safe and showed positive results. Some patients experienced a pause in cancer growth. Overall, pasritamig appears to be a safe option for those dealing with advanced prostate cancer. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Pasritamig is unique because it targets prostate cancer using a novel mechanism that differs from standard treatments like hormone therapy, chemotherapy, or radiation. Unlike these treatments, which often focus on disrupting hormone signals or directly attacking cancer cells with chemicals or radiation, pasritamig is designed to work at a molecular level, possibly offering a more tailored approach. Researchers are excited about pasritamig because it is administered intravenously in a step-up dosing manner, which may help optimize its effectiveness and manage potential side effects. This approach could provide new hope for patients, especially those who have not responded well to traditional therapies.

What evidence suggests that pasritamig might be an effective treatment for prostate cancer?

Research has shown that pasritamig, which participants in this trial may receive, may help treat advanced prostate cancer that no longer responds to standard hormone therapy. Previous studies found that pasritamig significantly lowered prostate-specific antigen (PSA) levels, with 42.4% of patients experiencing a 50% decrease. Additionally, pasritamig delayed cancer progression for about 7.85 months on average, allowing patients to live that long without their cancer worsening. It also achieved an overall response rate of 8.3%. These findings suggest that pasritamig could effectively manage cancer at this challenging stage. ^{1 2 4 5 6}

Who Is on the Research Team?

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Are You a Good Fit for This Trial?

This trial is for individuals with metastatic castration-resistant prostate cancer (mCRPC), which has spread beyond the prostate and doesn't respond to hormone therapies. Participants must meet certain health criteria not specified here.

Inclusion Criteria

I have undergone orchiectomy or am on hormone therapy for medical castration.

I can care for myself and am up and about more than 50% of my waking hours.

Next best treatment option is a clinical trial

Exclusion Criteria

I do not have another cancer that could affect this study's results.

I haven't had a serious blood clot in the last month.

I haven't taken immunosuppressive drugs for autoimmune disease in the last year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive pasritamig or placebo intravenously with best supportive care. Cycle 1 includes step-up doses on Day 1 and Day 8, and a target dose on Day 15. Cycle 1 duration is 8 weeks. From Cycle 2 onwards, participants receive the target dose every 6 weeks.

Up to 4 years and 8 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Pasritamig

Trial Overview The study tests Pasritamig combined with best supportive care (BSC) against a placebo plus BSC, focusing on how long patients live after starting treatment.

How Is the Trial Designed?

Group I: Pasritamig Plus Best Supportive Care (BSC) Experimental Treatment 2 Interventions

Participants will receive the step-up doses of pasritamig intravenously (IV) on Cycle 1 Day 1 (C1D1) and C1D8, and target dose of pasritamig IV on C1D15 (Cycle 1 duration is 8 weeks). From C2D1 onwards ( Cycle Duration is 6 week), participants will receive pasritamig target dose IV every 6 weeks. Participants will receive study treatment until confirmed progressive disease, death, intolerable toxicity, withdrawal of consent, or end of the study, whichever occurs first. All participants may receive BSC (defined as palliative external beam radiation, low dose steroids, pain medication, bone sparing agents, and needed palliative procedures) at the discretion of the physician.

Group II: Placebo Plus BSC Placebo Group 2 Interventions

Participants will receive the step-up doses of placebo IV on C1D1 and C1D8, and target dose of placebo on C1D15. From C2D1 onwards, participants will receive placebo target dose IV every 6 weeks and will receive study treatment until confirmed progressive disease, death, intolerable toxicity, withdrawal of consent, or end of the study, whichever occurs first. All participants may receive BSC at the discretion of the physician.

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials

1,022

Recruited

6,408,000+

Joaquin Duato

Janssen Research & Development, LLC

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD

Janssen Research & Development, LLC

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO-25-00678

Pasritamig, a First-in-Class, Bispecific T-Cell Engager ... In the RP2D efficacy population (n = 33), median radiographic progression-free survival was 7.85 (95% CI, 2.89 to not estimable) months, and 14 ...

2. jnj.com jnj.com/media-center/press-releases/johnson-johnson-unveils-first-in-human-results-for-pasritamig-showing-early-anti-tumor-activity-in-prostate-cancer

Pasritamig, a first-in-class bispecific T-cell-engaging ... Pasritamig appears well-tolerated and exhibits a promising antitumor activity in patients with metastatic castration-resistant prostate cancer (mCRPC).

3. urotoday.com urotoday.com/conference-highlights/asco-2025/asco-2025-prostate-cancer/160809-asco-2025-phase-1-study-results-of-jnj-78278343-pasritamig-in-mcrpc.html

Phase 1 Study Results of JNJ-78278343 (Pasritamig) in ... Pasritamig demonstrated a remarkable safety profile: · Pasritamig achieved durable responses and radiographic progression free survival that ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40450573/

Pasritamig, a First-in-Class, Bispecific T-Cell Engager ... In the RP2D efficacy population (n = 33), median radiographic progression-free survival was 7.85 (95% CI, 2.89 to not estimable) months, and 14 ...

5. onclive.com onclive.com/view/pasritamig-displays-safety-durable-disease-control-in-heavily-pretreated-mcrpc

Pasritamig Displays Safety, Durable Disease Control in ... Pasritamig showed promising efficacy in mCRPC, with 42.4% achieving a 50% PSA reduction and an 8.3% overall response rate. The median duration ...

6. urotoday.com urotoday.com/video-lectures/mcrpc-treatment/video/mediaitem/4984-pasritamig-safety-and-efficacy-data-from-metastatic-crpc-phase-i-study-capucine-baldini.html

Pasritamig Safety and Efficacy Data from Metastatic CRPC ... Despite being a phase I trial, efficacy was impressive with 42% of patients achieving PSA50 responses and median radiographic progression-free ...